WO2000033909A1 - Hollow, curved, superelastic medical needle - Google Patents

Hollow, curved, superelastic medical needle Download PDF

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Publication number
WO2000033909A1
WO2000033909A1 PCT/US1999/029182 US9929182W WO0033909A1 WO 2000033909 A1 WO2000033909 A1 WO 2000033909A1 US 9929182 W US9929182 W US 9929182W WO 0033909 A1 WO0033909 A1 WO 0033909A1
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WO
WIPO (PCT)
Prior art keywords
needle
cannula
infusion
assembly
needle assembly
Prior art date
Application number
PCT/US1999/029182
Other languages
English (en)
French (fr)
Inventor
Edward J. Morris
Robert L. Pakter
Original Assignee
Cook Incorporated
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cook Incorporated filed Critical Cook Incorporated
Priority to AU23558/00A priority Critical patent/AU736964B2/en
Priority to JP2000586398A priority patent/JP4342735B2/ja
Priority to CA002320097A priority patent/CA2320097C/en
Priority to EP99967240A priority patent/EP1054703B1/en
Priority to KR1020007008649A priority patent/KR20010040761A/ko
Priority to DE69920178T priority patent/DE69920178T2/de
Publication of WO2000033909A1 publication Critical patent/WO2000033909A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0041—Catheters; Hollow probes characterised by the form of the tubing pre-formed, e.g. specially adapted to fit with the anatomy of body channels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1662—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
    • A61B17/1671—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the spine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3478—Endoscopic needles, e.g. for infusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00261—Discectomy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M2025/0007—Epidural catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0266—Shape memory materials

Definitions

  • This invention relates generally to medical devices and more particularly, to needles that are curved for indirect infusion access within the body.
  • Background of the Invention Medical procedures involving the vertebrae are typically complicated because of the preciseness required to avoid both neural damage and injury to major blood vessels, as well as the indirect path that is usually required to access the treatment site. This is certainly the case when performing a vertebropiasty, a procedure whereby bone cement, most commonly methyl methacrylate, is injected into a vertebral body to provide stabilization and/or pain relief in selected patients having a spinal condition such as osteolytic metastasis and myeloma, painful or aggressive hemangioma (benign lesions of the spine), or painful osteoporotic vertebral collapse.
  • a spinal condition such as osteolytic metastasis and myeloma, painful or aggressive hemangioma (benign lesions of the spine), or painful osteoporotic vertebral collapse.
  • Standard treatment practice depends on the region of the spine being treated.
  • anterolateral access is used with a 1 5 gauge needle.
  • the large vessels adjacent to the vertebra are laterally manipulated by the radiologist to provide an access site between the vessels and the pharyngolarynx.
  • An upward access route is required because the needle must be introduced below the mandible.
  • a large 1 0 gauge needle is used following a transpedicular or posterolateral approach. The transpedicular route is preferred to avoid spinal nerve injury and to decrease the probability of the cement leaking out into tissues adjacent to the vertebral body.
  • the inability to adequately maneuver the needle cannula tip within a body or around structures is a major limitation of the straight needle. Additional needle sticks to complete a medical procedure provide discomfort to the patient and additional risk of leakage and other complications.
  • the tip In order to sufficiently access a vertebral body for complete infusion of cement, the tip must be able to be deflected at significantly large angles from the original axis. This would require that the needle have a distal bend so that it could be rotated to selectively direct the material.
  • Rigid curved needles are well known for suturing applications; however, adding anything more than a slight bend to an infusion needle limits its access path and ability to deeply penetrate tissue, especially bone.
  • a rigid curved needle would be unsuitable for use in a vertebropiasty procedure where the needle cannula must be driven through the bone and deep into the vertebral body using a relatively straight approach and maintained in place to avoid additional damage to the entry site. While the initial access must be done with a straight needle of sufficient strength to penetrate bone, the ideal approach would be to be able to direct a lateral infusion of cement following penetration, and then to withdraw the needle along its original path. Accomplishing this is problematic in that the density and resistance of the tissue at the treatment site can require that the inner infusion member be nearly as stiff as the outer piercing cannula. A certain degree of rigidity is required to be able to maneuver the inner member and accurately direct the flow of material.
  • an infusion needle made of a rigid superelastic material and having at least one preformed bend along the distal portion of its length.
  • the needle is used coaxially with a second hollow cannula for restraining the inner needle cannula in a substantially straight orientation during percutaneous introduction to the target site, whereby the inner needle cannula is deployed to resiliently return to its preformed configuration.
  • the ability of the preformed inner needle cannula to deflect laterally upon exiting the outer cannula allows it to infuse or aspirate material at multiple points within different planes in the body by rotating the inner infusion needle about its longitudinal axis.
  • the preferred material for the inner cannula is a superelastic, shape memory alloy such as nitinol (Ni-Ti); however, there are other non Ni-Ti alloys that may be used.
  • Ni-Ti nitinol
  • a nitinol alloy is selected that has properties whereby the temperature at which the martensitic to austenitic phase change occurs is lower than the working temperature of the device (i.e., room temperature). As described by Jervis in U.S. Patent No. 5,597,378 filed Oct.
  • a permanent bend may be heat set in a superelastic nitinol cannula by maintaining the cannula in the desired final shape while subjecting it to a prescribed high temperature for a specific time period.
  • the cannula can be elastically manipulated far beyond the point at which stainless steel or other metals would experience plastic deformation.
  • Nitinol and other superelastic materials when sufficiently deformed, undergo a local phase change at the point of stress to what is called “stress-induced martensite" (SIM). When the stress is released, the material resiliently returns to the austenitic state.
  • SIM stress-induced martensite
  • a second method of imparting a permanent bend to the material is by a process commonly known as cold working.
  • Cold working involves mechanically overstressing or overbending the superelastic cannula.
  • the material within the bending region undergoes a localized phase shift from austenite to martensite and does not fully return to its original shape.
  • the result is a permanent curve about the bending zone which has been locked in to at least a partial martensitic crystalline state.
  • the entire heat-annealed cannula is in a austenitic condition, even in the curved region, and only is temporarily transformed to martensite under sufficient bending stresses.
  • an introducer trocar or stylet are used with either the outer or inner needle cannula, depending on the luminal size of the needle, to facilitate access of tissue and/or prevent coring tissue into the distal tip of the device.
  • the infusion needle is introduced through the outer cannula after access has been established and the trocar or stylet is removed.
  • the inner cannula may slightly deform the outer cannula as the preformed bend is constrained within the outer cannula.
  • the outer cannula may be deflected a few degrees from its normal longitudinal axis at a point corresponding to the bend of the inner cannula. As the inner cannula is deployed from the outer cannula, it deflects laterally until the entire region of the bend is unsheathed.
  • the distal opening of the inner cannula is oriented at a large angle (preferably within the range of 60-90°) from the original longitudinal axis when the inner needle is fully deployed.
  • the ability of the inner cannula to deflect at a significant angle from the original longitudinal axis has great utility in a number of applications where straight access in required followed by redirection of the distal opening. This permits access to a different site without the necessity of withdrawing and reintroducing the needle.
  • a primary example of such a procedure is vertebropiasty in which infusion of the stabilizing cement with a straight needle often requires a second stick to provide a complete filling to stabilize the vertebral body while avoiding damage to delicate structures such as veins.
  • the larger outer needle cannula such as a coaxial Jamshidi-type needle
  • the outer needle includes an inner introducer trocar which is then replaced with a inner curved needle for infusion of the cement.
  • the device can also be adapted for aspirating material or serving as a conduit for the introduction of other devices.
  • the present invention can be used for a percutaneous corpectomy, a procedure which involves fusion and decompression of two or more vertebrae by first aspirating tissue from the damaged vertebral bodies, then introducing a carbon fiber composite cage packed with bone graft material to serve as scaffolding for the affected vertebrae. Once the cage is properly positioned, methyl methacrylate or another suitable material is infused into the vertebral bodies to secure the prosthesis.
  • the percutaneous corpectomy offers less trauma and with the reinforcement cage, provides superior rigidity over a conventional corpectomy utilizing bone graft material alone.
  • the coaxial needle can be adapted for paraspinal use to inject medicaments within the neural canal or epidural space as part as management and/or diagnosis of pain.
  • the outer cannula has a tip adapted for piercing soft tissue.
  • This outer needle cannula preferably about 21 gauge, is introduced percutaneously parallel to the spinal column along with an internal stylet with matched bevel to prevent coring tissue into the distal opening.
  • the stylet is removed and the curved needle, about 25 gauge, is inserted into the outer cannula.
  • the needle assembly is then maneuvered to contact a nerve root during a diagnostic procedure to help recreate pain symptoms of the patient.
  • the inner infusion needle also includes a stylet which is situated within the passageway of the needle as it is directed to the target site.
  • medicaments commonly steroids such as Celestone (injected with lidocaine), Kenalog, or methylprednisone are introduced to the treatment site.
  • the inner needle is then withdrawn into the outer sheath cannula and both are withdrawn from the patient.
  • Another use of the smaller gauge paraspinal needle is for diskography procedure. Diskography consists of injecting a contrast agent (preferably nonionic contrast media) directly into the disk to delineate the extent of any malformations or injury to the vertebral body.
  • Yet another embodiment of the invention solves the problem of infusion of ethanol into a tumor mass by utilizing a plurality of curved needle cannulae that can be deployed within an introducer cannula into the tumor where they radiate outward into an umbrella-shaped configuration. Therefore, infusion can take place at multiple points within the tumor to provide wider dispersion of the ethanol. Following treatment, the needle cannulae are withdrawn into the cannula and the device is removed from the patient.
  • one or more needle cannulae are located proximal to the distal end of the infusion needle. These proximally-located cannulae allow infusion of medicaments at different points along the length of the device.
  • the coaxial outer cannula includes a plurality of side apertures that allow the proximally-located needle cannulae to deploy after the infusion needle is placed at the desired location in the body and the outer cannula is withdrawn.
  • An outer sheath over the coaxial outer cannula selectively exposes the side apertures to permit the appropriate alignment of needle cannulae and apertures when there are multiple rows of each.
  • the value of the present invention includes any clinical situation where a straight approach is dictated and there is a need to avoid an obstructing structure in the entry path(a large vessel, bowel loop, etc.) Or redirect to a more lateral pathway to infuse medicaments or aspirate, such as to drain an abscess.
  • the present invention can function as a conduit for introducing and/or directing the path of other medical devices within the body such as radio-frequency ablation catheters or wire guides. This invention would allow a straight approach to a critical juncture whereafter the curved infusion needle can be deployed to precisely direct the device to the desired anatomical site, especially in situations such as a luminal bifurcation or when access to an ostium is required.
  • Another use of the present invention is to place the infusion needle in an scope such a bronchoscope or colonoscope which can serve as the outer constraining device. Under visualization, the inner needle then can be directed to perform a biopsy or other type of procedure.
  • FIG. 1 depicts a pictorial view of an illustrative embodiment of the curved needle cannula
  • FIG. 2 depicts top views of the outer needle cannula with introducer trocar and the inner curved needle cannula;
  • FIG. 3 depicts a top view of the inner curved needle cannula inside the outer needle cannula
  • FIG. 4 depicts a pictorial view of a second embodiment of the inner and outer cannula
  • FIG. 5 depicts a pictorial view of the inner cannula of FIG. 4 with an introducer stylet
  • FIGs. 6-8 depict side views of the inner cannula of FIG. 4 being deployed from the outer cannula;
  • FIGs. 9 depicts a partially sectioned view of the apparatus of FIG. 2 being introduced into a vertebral body
  • FIGs. 10-1 1 depict partially sectioned views of the apparatus of FIG. 2 infusing cement into a vertebral body.
  • FIG. 1 2 depicts an isometric view of a third embodiment of the present invention
  • FIG. 1 3 depicts a side view of the multi-directional infusion needle of FIG.
  • FIG. 14 depicts a side view of the needle of FIG. 1 3 being partially deployed
  • FIG. 1 5 depicts a side view of the trocar introducer used with the embodiment of FIG. 1 2;
  • FIG. 1 6 depicts a side view of the proximal assembly of FIG. 1 2;
  • FIG. 17 depicts a side view of a fourth embodiment of the present invention.
  • FIG. 1 8 depicts a partially-sectioned side view of the embodiment of FIG. 17 prior to deployment;
  • FIGs. 1 9-20 depict cross-sectional views of two embodiments of coaxial outer cannula depicted in FIG. 1 7; and
  • FIGs. 21 -22 depict pictorial views of a fifth embodiment of the present invention. Detailed Description
  • FIG. 1 depicts a pictorial view of an illustrative embodiment of the needle assembly 1 0 comprising an infusion needle 1 1 with a preformed bend 1 6 for lateral infusion or aspiration of medicaments and other materials.
  • the needle assembly 1 0 can comprise the infusion needle 1 1 alone or the infusion needle 1 1 in combination with other components that are part of this disclosure.
  • the infusion needle 1 1 as defined herein, comprises one or more needle cannulae having a preformed bend 1 6.
  • the first end 24 corresponds to the direction of the preformed bend 1 6 formed in needle cannula 1 3 of the infusion needle 1 1 .
  • the bend is formed in the nitinol needle cannula 1 3 by either the well-known process of deforming the cannula under extreme heat for a prescribed period of time, which produces a cannula entirely in the austenitic state, or by cold working the cannula, which involves applying a large amount of mechanical stress to deflect the cannula well beyond the desired amount of permanent bend.
  • Cold working permanently locks a portion of crystalline structure of the bending zone into at least a partial martensitic condition while the unstressed portions of the cannula remains in the austenitic state.
  • Cold worked Ni-Ti alloys are discussed in "Linear Superelasticity in Cold-Worked Ni-Ti", (Zadno and Duerig) pp.
  • the preformed bend 1 6 of the infusion needle 1 1 of the present invention comprises the distal portion of the needle cannula 1 3, preferably close to about 25% of the needle cannula 1 3 length in the embodiment of FIG. 1 .
  • this particular embodiment is suitable for penetrating a vertebral body to perform a vertebropiasty or percutaneous corpectomy procedure.
  • a more preferred range would be 1 2-1 7 gauge, with the most preferred cannula size being 1 3-1 5 gauge.
  • the larger gauge cannula has both the strength to penetrate dense bone material, as well as a sufficient lumen diameter to aspirate material from the vertebral body as well as infuse highly viscous bone cement, such as methyl methacrylate.
  • the preferred preformed bend 1 6 of the infusion needle 1 1 would have a constant diameter radius.
  • the preferred radius of the distal bend is approximately 3.0 cm for a 1 3 gauge needle, and approximately 2.5 cm for a 1 4 gauge needle.
  • the illustrative embodiment has a constant diameter bend radius, an increasing or decreasing radius bend could be employed for certain clinical applications.
  • FIG. 2 depicts a pair of needles to be used coaxially in that manner, including the infusion needle 1 1 of FIG. 1 and a coaxial outer cannula 1 2 for maintaining the inner infusion needle 1 1 in a substantially straight configuration while it is being introduced to the treatment site.
  • the embodiment depicted in FIG. 2 is Jamshidi-type needle (Manan Inc., Northbrook), a two-part needle assembly 43, and is most commonly used for accessing dense, hard tissue such as bone, fibrous material, etc.
  • the outer needle assembly 43 of this particular embodiment is comprised of a coaxial outer cannula 1 2 which includes a stainless steel cannula 1 9 with an inner passageway 21 that is sufficiently large to accommodate the inner infusion needle 1 1 .
  • the standard 1 1 gauge Jamshidi-type needle suitable for accessing a vertebral body would be used with 1 3 gauge inner curved needle.
  • Stainless steel cannula 1 9 is affixed proximally to a handle 26 and a connector hub 31 (shown in FIG. 3).
  • the connector hub 31 receives the second part of the two-part needle assembly 43, the coaxial outer cannula introducer 52 which in this embodiment, comprises a trocar 25.
  • the trocar hub 27 locks into the handle 26 of the coaxial outer cannula 1 2.
  • the beveled tip 30 of the trocar 25 extends approximately 5 mm beyond the distal tip 22 of the coaxial outer cannula 1 2 and assists in penetration.
  • the trocar 25 also serves to prevent the coaxial outer cannula 1 2 from coring a sample of bone or other material during access.
  • the trocar 25 is removed from the coaxial outer cannula 1 2 and the infusion needle 1 1 , is inserted into passageway 21 of the coaxial outer cannula 1 2 as shown in FIG.
  • an inner needle introducer stylet 45 can be introduced coaxially inside the infusion needle.
  • the inner needle introducer stylet 45 includes a handle 83 and a shaft 46 which is made of a flexible, high-tensile polymeric material such as polyetheretherketone (PEEK) to allow the stylet 45 to assume the contour of the preformed bend 1 6 after deployment.
  • PEEK polyetheretherketone
  • the inner needle introducer stylet 52 which helps prevent coring tissue into the passageway 21 of the coaxial outer cannula 1 2, is removed.
  • the tapered or "arrow" end 24 of the flange 23 of proximal hub 1 4 corresponds with the deflection plane 29 of the infusion needle 1 1 .
  • the opening of the tip 1 7 is deflected at an angle 44 of approximately 60° to 70° from the longitudinal axis 1 8 of the device.
  • the angle 44 of deflection can encompass a range of 30 to 1 10°, with a more preferred range of 40 to 90° for most applications.
  • FIG. 4 depicts a pictorial view of a second embodiment of the inner curved needle and an outer needle that are adapted for use in the injection of medicaments, contrast media, or other non-viscous agents.
  • the infusion needle 1 1 is comprised of a smaller gauge needle cannula 1 3, preferably around 25 gauge, mounted to a proximal hub 1 4.
  • the preformed bend 1 6 of individual needle cannula 1 3 has a slightly tighter radius than in the embodiments of FIGs. 1 -3.
  • the coaxial outer cannula 1 2 includes a correspondingly sized needle cannula 1 9, preferably around
  • FIG. 4 is used with a plurality of stylets that are inserted within both the inner and outer needles during their respective introduction into the body.
  • the first is an outer cannula introducer stylet 52 that is inserted into the passageway 21 of the coaxial outer cannula 1 2.
  • the coaxial outer cannula 1 2 and outer cannula introducer stylet 52 are inserted together into the patient.
  • the stylet which is comprised of a stainless steel stylet wire 46 with an attached standard plastic needle hub 47, prevents the coaxial outer cannula 1 2 from coring tissue into the passageway 21 at the distal tip 22.
  • outer cannula introducer stylet 52 is withdrawn from the coaxial outer cannula 1 2 and the infusion needle 1 1 and second introducer stylet 45 are together inserted into outer needle passageway 21 .
  • the inner needle introducer stylet 45 which is longer than outer cannula introducer stylet 52 in order to fit the longer infusion needle 1 1 , serves a similar function to the outer cannula introducer stylet 52 by preventing coring of tissue when the infusion needle 1 1 is deployed from the coaxial outer cannula 1 2.
  • the proximal hub 1 4 of the infusion needle 1 1 is adapted such that the hub 53 of the inner needle introducer stylet 45 locks together with proximal hub 14 to keep the two in alignment.
  • This locking mechanism includes a molded protuberance 49 on hub 53 that fits within a recess
  • FIGs. 6-8 depict the deployment of the infusion needle 1 1 from the outer needle cannula 1 2.
  • FIG. 6 depicts the infusion needle 1 1 during the initial stage of deployment from the coaxial outer cannula 1 2.
  • the preformed bend 1 6 of the infusion needle 1 1 is constrained by the cannula 1 9; however, as in the case of the embodiment of FIG.
  • the preformed bend 1 6 may be of sufficient stiffness to slightly deform the outer cannula 1 9 while the infusion needle 1 1 is inside the coaxial outer cannula 1 2. Despite this slight deformation, the coaxial outer cannula 12 is still substantially straight, as defined herein. As depicted in FIG. 7, the stress that the preformed bend 1 6 places on the outer cannula 1 9 is relaxed as the infusion needle 1 1 is further deployed; and the angle of deflection 44 (as measured from the longitudinal axis 1 8 of the coaxial outer cannula 1 2 to the opening at tip 1 7 of the infusion needle 1 1 ) is increased. As the infusion needle 1 1 is further deployed as depicted in FIG.
  • FIG. 8 fully exposing the preformed bend 1 6 to produce the largest possible angle of deflection 44, the unstressed outer cannula returns to a straight configuration.
  • the phenomenon depicted in FIGs. 6 to 8 is most noticeable when using smaller gauge cannulae as in the embodiment of FIGs. 4 to 5.
  • the larger gauge outer cannula of FIGs. 1 to 3 is more resistant to deformation than that of the second embodiment.
  • the tendency of the stressed outer cannula to deform is also very much dependent on the stiffness and radius of the preformed bend 1 6 as well as the thickness of the cannula wall and material used.
  • a stylet 45 as depicted in FIG.
  • FIGs. 9 to 1 1 depict the use of the present invention to perform a vertebropiasty procedure on a pathological vertebral body 33, using a transpedicular approach.
  • the coaxial outer cannula 1 2 with introducer trocar depicts the coaxial outer cannula 1 2 with introducer trocar
  • the transpedicular route of access places the needle between the mammillary process 34 and accessory process 35 of the vertebral arch 55.
  • the vertebral arch 55 is attached posteriorly to the vertebral body 33 and together, they comprise the vertebra 54 and form the walls of the vertebral foramen 36.
  • FIG. 1 0 depicts the infusion needle 1 1 infusing bone cement 41 , commonly methyl methacrylate, into the vertebral body 33 to provide it with improved structural integrity.
  • the infusion needle 1 1 can be partially withdrawn or rotated to obtain a more complete filling or avoid the network of vertebral veins.
  • the infusion needle 1 1 is withdrawn back into the coaxial outer cannula 1 2 and both are removed from the vertebral body 33.
  • FIG. 1 2 depicts a perspective view of the present invention in which the needle assembly 1 0 comprises a multiple needle assembly 70 useful in infusion of ethanol or other medicaments into a tumor.
  • the needle assembly 1 0 comprises an infusion needle 1 1 , which in this embodiment includes a multiple needle assembly 70 comprising a plurality of needle cannulae 1 3, each ' having a preformed bend 1 6; a proximal assembly 58 for constraining the multiple needle assembly 70, and a coaxial outer cannula 1 2 for introducing the multiple needle assembly 70 to its anatomical target.
  • the multiple needle assembly 70 shown in FIG. 1 3, includes a base cannula 56 affixed to a proximal hub 1 4 such as a standard female luer fitting.
  • a plurality of needle cannulae 1 3 are manifolded into the base cannula 56, evenly spaced in an umbrella configuration 75, and affixed in place with a solder joint 57.
  • five needle cannulae 1 3 are used, although two to as many as appropriate for the given cannula size can be used.
  • the needle cannulae 1 3 are preferably made of nitinol that is either annealed or cold-worked to produce the preformed bend 1 6.
  • the coaxial outer cannula 1 2 has an O.D. of approximately 0.072" and an I.D.
  • FIG. 1 4 Deployment of the curved needle cannulae 1 3 of the multiple needle assembly 70 is depicted in FIG. 1 4.
  • the needle cannulae 1 3 are restrained by the coaxial outer cannula 1 2 until the multiple needle assembly 70 is advanced, exposing the distal end portions of needle cannulae 1 3 at distal end 22 of coaxial outer cannula 1 2, whereby they radiate outward to assume, when fully advanced, the umbrella configuration 75 of FIG. 1 3.
  • FIG. 1 5 depicts a side view of an outer needle assembly comprising a coaxial outer cannula 1 2 and outer cannula introducer stylet 52 used in placement of the multiple needle assembly 70 of FIGs. 1 2-1 4.
  • the outer cannula introducer stylet 52 is inserted into passageway 21 of coaxial outer cannula 1 2 with the male proximal hub 47 of the outer cannula introducer stylet 52 fitting into the female proximal hub 20 of the coaxial outer cannula 1 2 when the outer cannula introducer stylet 52 is fully advanced.
  • the outer cannula introducer stylet 52 includes a sharp tip 63, such as the diamond-shape tip depicted, for penetrating tissue.
  • the outer cannula introducer stylet 52 and coaxial outer cannula 1 2 are introduced percutaneously into the liver or kidney and placed at the desired treatment location.
  • the outer cannula introducer stylet 52 is then removed.
  • the proximal assembly 58 with the preloaded multiple needle assembly is then advanced into the coaxial outer cannula 1 2 which remains in the patient.
  • the coaxial outer cannula has an O.D. of 0.095" and I.D. of about 0.076", while the O.D. of the inner stylet is about 0.068" .
  • FIG. 1 6 depicts a side view of the proximal assembly 58 of FIG. 1 2.
  • the proximal assembly 58 includes a distal male adaptor 60 connected to an intermediate cannula 59 that is sufficiently large to accommodate the multiple needle assembly 70.
  • proximal assembly female adaptor 61 At the proximal end of the intermediate cannula 59 is proximal assembly female adaptor 61 which is connected proximally to a proximal assembly hub 62, such as a Tuohy-Borst adaptor.
  • the proximal assembly hub 62 is utilized by the physician during manipulation of the device.
  • FIGs. 21 -22 depict a variation of the needle assembly 10 of FIG. 1 2 in which the infusion needle 1 1 and the coaxial outer cannula 1 2 are connected to a coaxial handle 76 used to advance and deploy the multiple needle assembly 70 from the constraints of the coaxial outer cannula 1 2.
  • the coaxial handle 76 comprises a stationary outer component 77 that fits over the base cannula 56 of the multiple needle assembly 70 and attaches to proximal hub 14; and a slidable inner component 78 that attaches proximally to proximal hub 20.
  • the slidable inner component 78 further comprises a thumb piece 79 used by the physician to advance or retract the coaxial outer cannula 1 2 as the slidable inner component 78 retracts into the stationary outer component 77.
  • a thumb piece 79 used by the physician to advance or retract the coaxial outer cannula 1 2 as the slidable inner component 78 retracts into the stationary outer component 77.
  • FIG. 21 the needle assembly is depicted in the introducer position with he thumb piece 79 advanced fully forward within the slot 80 in the outer slidable component 77.
  • FIG. 22 depicts the deployment state of the needle assembly 10 in which the thumb piece 79 has been moved to the most proximal position within the slot 80. In this position, the coaxial outer cannula 1 2 is retracted to fully expose the plurality of needle cannulae 1 3 which can assume their unconstrained configuration that includes the preformed bends 1 6. It should be noted that this type of handle can be used with both the multiple and single infusion needle where a introducer trocar or stylet is not required.
  • Other well-known types of coaxial handles 76 include, but are not limited to, screw-type, rachet-type, or trigger-activated handles which allows the coaxial outer cannula 1 2 to be longitudinally displaced relative to the infusion needle 1 1 .
  • the distal tip 22 of the coaxial outer cannula 1 2 can be shaped into a needle point such as depicted, or a non-coring point to help maintain an open outer cannula passageway 21 .
  • a syringe or other reservoir container can be attached to proximal hub 14 as an infusate source or for collection of aspirated material.
  • the reservoir such as a syringe, can be incorporated internally within the coaxial handle 76 of the needle assembly 10, or integrally attached thereto.
  • FIGs. 1 7-20 Another embodiment of the multiple needle assembly 70 is depicted in FIGs. 1 7-20 whereby there are one or more groupings of proximally-located needles 73 in addition to the distally-located needles 74 that are similar to the embodiment of FIG. 1 2.
  • proximally-located needles 73 By locating needle cannulae 1 3 proximal to those at the distal end, wider dispersal and coverage is attained for infusion of medicaments.
  • the needle cannulae 1 3 of the proximally-located and distally-located needles 73,74 can vary in their configuration, length, number, and how they are attached to the base cannula 56 (FIG. 1 3).
  • individual needle cannulae 1 3 within an umbrella configuration 75 or between proximally-located and distally-located needles 73,74 can be longer, or have a different radius than others to vary the distribution pattern of the infusate. In one embodiment depicted in FIGs.
  • each pair of oppositely-disposed needle cannulae 1 3 within a grouping of four proximally-located needles 73 are longitudinally offset with respect to the adjacent pair located 90° therefrom, as are the side apertures 67 from which they emerge.
  • possibilities include, but are not limited to, having all needle cannulae 1 3 attaching to a single base cannula 56; dividing the base cannula 56 such that a separate portion extends distally from the proximally-located needles 73 to join the distally- located needles 74; or elimination of the base cannula 56 such that the needle cannulae 1 3 of the multiple needle assembly 70 are separate and run the length of the infusion needle 1 1 .
  • FIG. 1 8 shows a sectioned view of the needle assembly of FIG. 1 7 in which the needle cannulae 1 3 are constrained in the introduction position.
  • An introducer cannula 68 is used to selectively expose the side apertures 67 in embodiments where the arrangement of needles is such that individual needle cannulae 1 3 may prematurely exit a non-designated hole or row, preventing or delaying proper deployment of the multiple needle assembly 70.
  • FIGs. 1 9-20 illustrate intraluminal guides 69 to help facilitate proper alignment of needle cannulae 1 3 with a designated side aperture 67.
  • a series of ridges 71 within the passageway 21 of the coaxial outer cannula 1 2 help guide the needle cannulae 1 3 to align with a designated side aperture 67.
  • FIG. 20 depicts an alternative intraluminal guide 69 in which the needle cannulae 1 3 travel longitudinally within grooves 72 that are made in the inside wall of the passageway 21 .

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Surgery (AREA)
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  • Medical Informatics (AREA)
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  • Pathology (AREA)
  • Dentistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Surgical Instruments (AREA)
  • Prostheses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
PCT/US1999/029182 1998-12-09 1999-12-09 Hollow, curved, superelastic medical needle WO2000033909A1 (en)

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AU23558/00A AU736964B2 (en) 1998-12-09 1999-12-09 Hollow, curved, superelastic medical needle
JP2000586398A JP4342735B2 (ja) 1998-12-09 1999-12-09 中空で湾曲した超弾力的医療用針
CA002320097A CA2320097C (en) 1998-12-09 1999-12-09 Hollow, curved, superelastic medical needle
EP99967240A EP1054703B1 (en) 1998-12-09 1999-12-09 Hollow, curved, superelastic medical needle
KR1020007008649A KR20010040761A (ko) 1998-12-09 1999-12-09 중공의 만곡형 초탄성 의료용 니들
DE69920178T DE69920178T2 (de) 1998-12-09 1999-12-09 Super-elastische gebogene hohlnadel zur medizinischen verwendung

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US60/111,624 1998-12-09
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US9802024B2 (en) 2017-10-31

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